Oncolytics Pushes Its Pipeline Further

Oncolytics Biotech Inc.(NASDAQ: ONCY) is another company pushing the limits of immunotherapeutics. Yesterday, they announced that enrollment had concluded in a randomized Phase 2 ovarian cancer study using Reolysin. They currently have 11 ongoing studies.

This study will be a randomized phase 2 trial of weekly paclitaxel versus weekly paclitaxel with Reolysin in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG186H). They recently also began a Phase 1 trial in pediatric patients with relapsed or refractory solid tumors and announced some promising publications regarding their lead candidate, Reolysin.

Oncoloytics' Reolysin is an immunotherapy that works by using the reovirus to replicate in cancer cells that with a mutation known as an “activated Ras pathway,” but it spares normal cells; the reovirus then replicates in those cells with an active Ras signaling pathway, eventually killing the host cell and continuing this cycle. It has made some impressive results as a monotherapy, but has a particularly synergistic effect in combination with certain chemotherapeutics.

With ONCY conducting eleven clinical trials in the U.K. and U.S., it makes you wonder how they've done it without heavily diluting. This has only been possible thru collaborative agreements with the National Cancer Institute (NCI) in the U.S. to conduct multiple clinical trials, the Cancer Therapy and Research Center at the University of Texas Health Science Center has committed to funding up to five Phase II clinical trials using Reolysin in combination with chemotherapy against a variety of advanced cancers, and sponsored studies in the UK. Oncolytics Biotech and clinical collaborators are actively testing Reolysin in ovarian cancer, colorectal cancer (only patients with mutated Kras gene), melanoma, sarcoma, and pancreatic cancer.

Financially, these agreements have kept them afloat except for the occasional capital raise. More importantly, they are running a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers that's being conducted under a Special Protocol Assessment (SPA). As we get close to top-line results later on down the road, you can be sure that volatility will increase. The Street and big pharma will be watching.

With a pipeline of 11 ongoing trials, we can expect ONCY to begin announcing results from these trials over the next 1-2 years. Note that they raised roughly $28 million back in early November and should have enough cash to see them through until 2012. By then, we should have more complete knowledge on the potential for Reolysin.